Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall HYDRATOME RX 49-20MM/260CM Material Number: M00583000 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HYDRATOME RX 49-30MM/260CM Material Number: M00583010 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 39-20-260-025 Material Number: M00573080 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 39-20-450-025 Material Number: M00573090 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 39-30-260-025 Material Number: M00573100 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 39-30-450-025 Material Number: M00573110 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 44-20-260-035 Material Number: M00573040 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 44-20-450-035 Material Number: M00573050 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 44-30-260-035 Material Number: M00573060 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 44-30-450-035 Material Number: M00573070 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 49-20-260-035 Material Number: M00573000 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 49-30-260-035 Material Number: M00573020 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall JAGTOME RX 49-30-450-035 Material Number: M00573030 Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441… Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380… Sterility of device is compromised due to a sterile barrier breach Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LINQ II Insertable Cardiac Monitor Devices may lose functionality due to susceptibility to moisture ingress. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York, Pennsylvania and Virginia named
- Medical device recall (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mycoplasma genitalium Control Panel (Inactivated Pellet) Distributed product did not undergo proper release testing. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement Report18 statesnamed in where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereArizona, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall Wright Medical Technology, Inc An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereFlorida, Nebraska and Texas
- Medical device recall LYFO Disk LYFO Disk Catalog #0983L is to contain Candida tropicalis. Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 23, 2022ClassClass IIIStatusCompletedWhereNationwide, and Colorado, Georgia and Ohio named
- Medical device recall SAM CHEST SEAL Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing… Class IIFDA’s classMar 23, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 23, 2022ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Massachusetts, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Texas, Virginia and Washington
- Medical device recall Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5” Spinal Needle with Manometer Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LUMBAR PUNCTURE DRUG FREE TRAY 22G Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SAFE-T PLUS ATRAUMATIC ADULT LP TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected… Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected… Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected… Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected… Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected… Class IIIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall BioPlex 2200 Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent… Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BioPlex 2200 Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent… Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated) If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. Class IIFDA’s classMar 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 23, 2022ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 16, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 16, 2022ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test) COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 16, 2022ClassClass IStatusOngoingWhereNationwide, and California, North Carolina, Nevada, Ohio, Tennessee and Texas named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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